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Dermoia manuka honey eczema cream - Medication Information

Product NDC Code 83524-407
Drug Name

Dermoia manuka honey eczema cream

Type Brand
Pharm Class Allergens [CS],
Cell-mediated Immunity [PE],
Dietary Proteins [CS],
Grain Proteins [EXT],
Increased Histamine Release [PE],
Non-Standardized Food Allergenic Extract [EPC],
Non-Standardized Plant Allergenic Extract [EPC],
Plant Proteins [CS]
Active Ingredients
Oatmeal 10 mg/ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 240651
Application Number M016
Labeler Name TREASUREWISE LLC
Packages
Package NDC Code Description
83524-407-00 120 ml in 1 jar (83524-407-00)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Colloidal Oatmeal 1% Purpose Skin Protectant

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Apply as needed

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: Allantoin, Aloe Barbadensis Leaf (aloe Vera Gel) Juice, Arnica Montana Flower Extract, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Ceramide NG, Ceramide NP, Cetearyl Alcohol, Chamomilia Recutita (Chamomile) Extract, Citric Acid, dl-Panthenol, Ethylhexylglycerin, Euterpe Oleracea (Acai) Extract, Glycerin, Glyceryl Stearate, Hyaluronic Acid, Isopropyl Myristate, Magnesium Aluminum Silicate, Manuka Honey, Melaleuca Alternifolia (Tea Tree) Oil, Niacinamide, Linum Usitatissimum (Flaxseed) Oil, Oryza Sativa (Rice) Bran Oil, Passiflora Incarnata (Passion Fruit) Extract, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid, Tocopheryl Acetate (Vitamin E), Xanthan Gum.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses Temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema poison ivy, oak, or sumac insect bites

Purpose

Information about the drug product’s indications for use.
Purpose Skin Protectant

Spl product data elements

Usually a list of ingredients in a drug product.
DERMOIA Manuka Honey Eczema Cream OATMEAL ALLANTOIN ALOE VERA LEAF ARNICA MONTANA FLOWER WATER SHEA BUTTER CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES CERAMIDE NG CERAMIDE NP CETOSTEARYL ALCOHOL CHAMOMILE CITRIC ACID MONOHYDRATE PANTHENOL ETHYLHEXYLGLYCERIN ACAI GLYCERIN GLYCERYL MONOSTEARATE HYALURONIC ACID ISOPROPYL MYRISTATE MAGNESIUM ALUMINUM SILICATE TEA TREE OIL NIACINAMIDE FLAX SEED RICE BRAN OIL AVOCADO OIL PHENOXYETHANOL JOJOBA OIL STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE XANTHAN GUM OATMEAL OATMEAL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package Labeling: Label

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Other Information: Protect the product in this container from excessive heat and direct sun

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product do not get into eyes

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or beast-feeding, ask a health professional before use.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings: For external use only When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or beast-feeding, ask a health professional before use.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API